Research Project on Reminders and Self-Sampling Can Increase Participation in Gynecology Cell Sampling - Preventive Examination Against Cervical Cancer.
1 other identifier
interventional
20,000
1 country
6
Brief Summary
Prevention of cervical cancer with cervical screening is one of the most successful screening activities in medicine. In Sweden, screening was implemented in the 1960s and has since prevented tens of thousands of women from having cervical cancer. Individual invitations to screening result in increased attendance therefore evaluating strategies for reaching women through invitations is particularly valuable. Women who regularly attend screening following an invitation reduce their risk of cervical cancer by as much as 90%. Of the women who are diagnosed with cervical cancer (about 550 women per year in Sweden), as many as 38% did not participate in the screening. Invitations for screening are sent to the entire population in Sweden aged 23-70. The current coverage of screening is 82.9%, which represents the proportion of women ages 23-70 who attend according to recommendations. In addition, many women are sporadic attenders who reduce their risk for cancer somewhat. The highest cancer risk is seen among those women who have never participated as well as women who have had a history of precancerous lesions or HPV infection but have not been followed-up. Cervical cancer is the first form of cancer for which there are approved molecular screening tests (HPV test). Unlike the older screening method (cytology), self-collected samples can be analyzed for HPV (the analysis method is so sensitive that it does not matter if the sample is not optimally taken). Invitations and reminders about cervical screening are sent by letter to the woman's home address (about 3 million letters per year in Sweden). This strategy results in a waste of resources and has a negative environmental impact. Regarding reminders, we have seen in previous research that the effect is not optimal. When sending a physical reminder letter to women who have not participated in more than 10 years (current routine), only 2% of the women invited came for sampling. Reminders with SMS are now standard for many businesses in society, such as car testing or dental appointments. It is inexpensive, saves the environment and there are studies that suggest it is more effective than sending physical letters. In this study, we intend to investigate whether SMS reminders, electronic letters, and physical letters for screening lead to increased participation and thus to a higher proportion of detected, treatable precursors of cervical cancer compared to before.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2019
CompletedStudy Start
First participant enrolled
August 19, 2019
CompletedFirst Posted
Study publicly available on registry
August 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
January 14, 2025
January 1, 2025
10.8 years
August 18, 2019
January 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of women responding to summon
Participation rate in screening after summons.
Measured from the date of the summons until 12 months after the summons
Secondary Outcomes (3)
Number of positive screens
Measured from the date of the summons until 12 months after the summons
Rate of precursors of cancer
Measured from the date of the summons until 12 months after the summons
Rate of cancer
Measured from the date of the summons until 12 months after the summons
Study Arms (1)
HPV self sampling test ordered
OTHERAn invitation to order a HPV self sampling test through an online application will be sent by SMS or electronic letter.
Interventions
2019-2021 - A Cobas PCR Female swab sample packet will be sent. Response rates (participation) will be measured. 2022 and onwards - A FLOQSwab and corresponding sample tube for analysis on the BD COR platform will be sent.
Eligibility Criteria
You may qualify if:
- Women resident in Region Skane who either: 1) have had glandular cell transformation that has not been followed-up, 2) are older than 65 years and have had cell transformation that has not been followed-up or who have not participated in screening during the last 10 years, 3) women who have not been screened for more than 15 years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Region Skanecollaborator
Study Sites (6)
Northern Region
Luleå, Norrbotten County, 901 87, Sweden
Southern Region
Lund, Skåne County, 221 00, Sweden
Western Region
Gothenburg, Västra Götaland County, 413 45, Sweden
Southeast Region
Jönköping, 581 85, Sweden
Region of Stockholm-Gotland
Stockholm, 112 18, Sweden
Region of Middle Sweden
Uppsala, 751 85, Sweden
Related Publications (3)
Elfstrom KM, Sundstrom K, Andersson S, Bzhalava Z, Carlsten Thor A, Gzoul Z, Ohman D, Lamin H, Eklund C, Dillner J, Tornberg S. Increasing participation in cervical screening by targeting long-term nonattenders: Randomized health services study. Int J Cancer. 2019 Dec 1;145(11):3033-3039. doi: 10.1002/ijc.32374. Epub 2019 May 10.
PMID: 31032904BACKGROUNDArroyo Muhr LS, Wang J, Hassan SS, Yilmaz E, Elfstrom MK, Dillner J. Nationwide registry-based trial of risk-stratified cervical screening. Int J Cancer. 2025 Jan 15;156(2):379-388. doi: 10.1002/ijc.35142. Epub 2024 Aug 15.
PMID: 39146489RESULTWang J, Elfstrom KM, Borgfeldt C, Dillner J. A pilot study of risk-stratified cervical cancer screening. Open Res Eur. 2022 Sep 1;1:84. doi: 10.12688/openreseurope.13398.2. eCollection 2021.
PMID: 37645164RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miriam Elfström, PhD
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Affiliated Researcher
Study Record Dates
First Submitted
August 18, 2019
First Posted
August 20, 2019
Study Start
August 19, 2019
Primary Completion (Estimated)
June 1, 2030
Study Completion (Estimated)
June 1, 2030
Last Updated
January 14, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share